NCT06249763

Brief Summary

The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are:

  • What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis?
  • What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis?
  • What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms? During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to:
  • Eat gluten free and two daily granola bars delivered by the research team
  • Collect blood, stool and urine samples
  • Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 11, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

8 months

First QC Date

January 31, 2024

Last Update Submit

January 8, 2026

Conditions

Inflammatory Bowel DiseasesUlcerative Colitis

Keywords

BiomarkersTreatment outcomeGlutenDietMicrobiomeGastrointestinal symptomsFatigue

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal symptoms

    The Gastrointestinal Symptom Rating Scale (GSRS)

    1 week

Secondary Outcomes (14)

  • Fatigue

    1 week

  • Disease activity

    1 week

  • Symptom burden

    1 week

  • Functional status

    1 week

  • Disease-related health burden

    1 week

  • +9 more secondary outcomes

Other Outcomes (2)

  • Microbiome data

    1 week

  • Potential biomarkers

    1 week

Study Arms (2)

High gluten

EXPERIMENTAL

Participants complete both study arms in a crossover design separated by a washout period.

Dietary Supplement: Gluten free diet

Gluten free

PLACEBO COMPARATOR

Participants complete both study arms in a crossover design separated by a washout period.

Dietary Supplement: High gluten diet

Interventions

High gluten dietDIETARY_SUPPLEMENT

Trial period A: gluten free diet added daily granola bars with 10 g gluten/day (intervention).

Also known as: G (gluten)
Gluten free
Gluten free dietDIETARY_SUPPLEMENT

Trial period B: gluten free diet added daily granola bars with \<1 g gluten/day (placebo).

Also known as: GF (gluten free)
High gluten

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis: Ulcerative Colitis (UC)
  • Language: Can read and understand Danish

You may not qualify if:

  • Age: \<18 years
  • Treatment: Previous operation for UC
  • Concomitant diagnoses: Coeliac Disease (positive Immunoglobolin A against transglutaminase, TGA-IgA) or any cancer diagnosis
  • Other: Taking probiotics, are pregnant or breastfeeding, or have nut or wheat allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark, 6200, Denmark

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeFatigue

Interventions

GlutensDiet, Gluten-Free

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage ProteinsDiet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Vibeke Andersen, Prof

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants are randomised by an external source. Participants, care provider, investigator and outcomes assessor will be blinded to the randomisation. In case of adverse events, the randomization will be revealed to the investigator.
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2024

First Posted

February 8, 2024

Study Start

March 11, 2024

Primary Completion

October 30, 2024

Study Completion

October 30, 2024

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

DK(1)